How Medical Research Leads to New Patent Ideas

A new patent pending medical device – based on scientific research – proves even simple innovations to existing products can be very lucrative.

Surgical masks haven't changed too much since 1918. It was the year of the Spanish Flu pandemic, and surgeons adopted cotton gauze masks during surgery to protect themselves from patient diseases.Mask Medical Patent

The interest in masks as germ barriers was based on the work of Joseph Lister, who developed asuccessful system of antiseptic surgery (based on Louis Pasteur's' at the time controversial germ theory).

Since then, there has been much innovation in surgical masks. Lighter materials. More comfortable straps. Anti-glare strips. And of course, bacterial filtration. All worthy of new patents.

A New Patent for an Old Medical Invention

Despite all the new additions, one major problem remained…unique facial features.

Since surgical masks are a mass-produced item, there is no possible way for them to perfectly fit every face. And surgical masks that do not have a completely air-tight fit do not completely prevent the spread of germs.

A new medical patent aims to change that.

I recently came across a press release about a patent from Cantel Medical Corporation for a new type of surgical mask. And it shows how medical research can lead to new patents.  Click here if you would like to read the press release.   One paragraph in particular reveals how this new patent resulted directly from a medical study:

A recent study, published in the September 2010 issue of the American Journal of Infection Control quantified the ability of medical face masks to minimize the spread of infection.  The study, entitled "Quantifying Exposure Risk and Mask Protection," found that a tighter-fitting mask may offer as much as 100-fold greater infection control benefit than standard, loose-fitting masks.

The press release goes on to explain how ill fitting masks are "rolling out a red carpet for dangerous infectious material to bypass the mask" and that proper fitting face masks are cheap insurance against infectious disease.

Takeaways for the Medical Device Inventor

 Studies and medical research are great starting points for possible medical patents for two reasons:

1.    Facts and figures of what needs to be improvedmedical patent

Usefulness is one of the first criteria the patent examiners use to determine if an idea is patentable. The study mentioned above found that "tighter-fitting masks may offer as much as 100-fold greater infection control benefit than standard, loose-fitting masks."

2.    Proof there is a need.

There isn't much good to a new medical or dental idea, unless there is a need, or demand for the innovation.  Looking into medical studies is one way to try and keep your finger on the pulse of medical demand.  Including a reference to the study in the patent application is sometimes a good idea and can be very persuasive to a Patent Examiner of this need.

Spending some time digging through medical research could give you the next big idea.

Supreme Court Case Could Change Patenting and Prosecution of Medical Software Patents

I am awaiting my red-eye flight back home to Fort Lauderdale, Florida, after attending the 2nd Annual Medical Device Patenting Conference in San Francisco.  It was a great conference on patenting with an emphasis on medical devices, software, and processes. 

There were a number of in-house and outside attorneys that focus their practices on the patenting of medical devices.  A lot of ground was covered over the two day conference.

One of the highlights for me was the opportunity to hear attorney Michael Jakes and his take on the Bilski case before the Supreme Court on the patentability of business methods.  For the non-patent attorneys out there, the Supreme Court recently heard oral arguments on the patentability of business methods and processes and Michael Jakes is the attorney that filed the brief seeking certiori and argued before the Supreme Court on behalf of Bilski.  The Supreme Court has not made a final decision as of yet.  This decision will have a major impact on the patentability of medical software, methods, and processes.

A summary of the procedural history and background of the Bilski case is available on Wikipedia and you can link to it from here.

Single Letter Wrong in Medical Patent on Heart Surgury Solution Spells Disaster

Osmolarity  vs. Osmolality - What a difference a single letter makes! 

Can getting a single letter of the alphabet wrong in an issued patent spell disaster when it comes to litigating against infringers?  Unless the mistake is seen as being a minor typographical error that can be corrected by filing a certificate of correction, the answer is a resounding yes.

 

Hats off to Peter Zura of The 271 Patent Blog for his post on Central Admixure Pharmacy Services v. Advanced Cardiac Solutions (06-13-07).

 In this case, Central Admixture Pharmacy Services sued Advanced Cardiac Solutions for patent infringment relating to a chemical solution used duriing heart surgery. 

A certificate of correction was sought on the patent and was issued by the patent office to replace all instances of the word "osmolarity" with the word "osmolality".

You might be thinking that all the certificate does is change the "R" in osmolaRity with a "L" so that it reads osmolaLity.  Well, yes, BUT.... 

Whether or not the certificate of correction is proper depends upon whether the change is a clerical or typographical nature or if it constitutes new matter or would require re-examination.  Although the district court found the certificate of correction proper, the CAFC disagreed and found that the result of the correction was to broaden the claims since the corrected claims using the term osmolaLity cover less concentrated solutions than the original osmolaRity.

Yikes!  Needless to say, non-technical proofreaders or computerized spell-check and grammar checking programs (gasp!) are not adequate alternatives to a careful final review of a patent application by someone familiar with the technical vocabulary of the invention.

Patent Approved for Hythiam's Alcohol Treatment Program

       As a Florida Patent Attorney, I track the news relevant to innovators in the medical field and post them here in my blog. Rather than straight reporting, one of the things I do is to give you insights you can use in your own innovations. For instance, today I read that the U.S. Patent Office has issued a patent for Hythiam Inc.'s PROMETA® alcohol and chemical dependence treatment program. I'll give you the scoop on what their patent covers, but I'll also point out the larger health trends the patent links to with the aim of spurring on your own ideation development.

       First, the scoop.

       According to an article at PharmaLive.com (Business Wire, LA, January 10, 2008) PROMETA® is a patented treatment program designed for healthcare providers with patients dependent on alcohol, cocaine, and methamphetamine independently or in combination. It's a holistic treatment program that incorporates nutritional supplements, psychosocial/other therapies chosen by the patient and her treatment provider, and FDA-approved medication given orally and intravenously, which are "separately administered in a unique dosing algorithm."

        As with any treatment program, PROMETA® was developed with the goal of "sustained recovery," What makes it patentable is partly the specifics of the integrated approach and partly the integration itself, which comes at alcohol and chemical addiction from disparate perspectives: the psychology of the individual on his own and in regard to his social environment, his physical health and potentially associated nutritional deficiencies, and a medical/pharmacological perspective.

       And, herein lies the insight.

       This treatment program fuses three macro cultural trends: 1.) An increasing emphasis on the mind-body connection; 2.) an underlying belief that no one perspective is universally "right;" and 3.) a belief that success with patients is borne partly in their own sense of responsibility and involvement.

         Interest in the mind-body connection in particular is a trend that has continued to grow over the last several years, and you can see this in patented products in virtually every category, including fitness, publishing, alternative health practices, the expansion of nutraceuticals into even our soda, etc.

        So, looking at the innovation you're currently or considering working on: Do any of these trends factor in? Could/should they? Or, is there another macro trend evident in your design? Honing in on a trend at play in the larger culture is a way of sharpening your idea and its development. I'm always looking for ways larger cultural trends impact and push forward innovation and would love to help keep the good ideas going with patents and trademarks that protect original, ingenious thinking.

        Contact me if you have an idea you'd like to protect - (866) 433-2288.

Patent office overstretched due to increased workload - WIPO Report

The WIPO Patent Report, 2007 Edition, mentions that,

Increasing demand has led to increases in workload in some patent offices, although the number of patent applications pending examination differs significantly from one office to another. The United States of America had more than 900,000 pending applications in 2005, with Japan having the next largest number of pending applications (according to available data).

The following data will give you a better picture about this trend –

·        In 2005, about 1,660,000 patent applications were filed worldwide, which is an increase of 7% over 2004.

·        The average annual rate of increase in total patent filings since 1995 is 4.7%.

A bulk of this activity is concentrated in the US and medical technology patents lead the pack. I have already mentioned before how this surge is being accompanied by patent invalidation due to improper patenting methods being followed. With such heightened level of activity, it is becoming more and more important to get professional help while drafting patents, as every error is going to multiply the delays in the process, given the overburdened nature of the patent office at the present juncture.

Are Patent Rulings Impacting Court Cases?

The Wall Street Journal sure thinks so. Here is an excerpt from a WSJ article titled ‘How a Patent Ruling Is Changing Court Cases’ that drives the point home –

Last week, a federal judge in San Francisco who previously had allowed a patent-infringement lawsuit [by Friskit] to proceed against RealNetworks Inc. changed course and dismissed the case, citing the Supreme Court's April ruling in KSR v. Teleflex. The case is believed to be the first in which a trial-court judge has reversed his position and dismissed a case in the defendant's favor, citing the KSR decision.

"The Supreme Court has made it clear what it thinks," the judge said at a hearing in the case. "Patents are being issued on obvious inventions, and it tightened the reins."

The Supreme Court laid out the obviousness doctrine in 1851, saying that a patent requires more "skill and ingenuity" than that of "an ordinary mechanic acquainted with the business." Since virtually every litigated patent case includes an assertion of obviousness, and since the U.S. patent office examines patent applications for obviousness, many legal commentators have called KSR the most important patent case in decades.

"Patentees have long had the upper hand in patent litigation but the KSR case has shifted that balance of power back to defendants," said Dennis Crouch, a law professor at the University of Missouri.

This means that applicants need to be much more careful while putting in their applications if they want the proceedings to progress without any hitches. The best, and ultimately cheapest, option would be to let experienced professionals handle the application procedure from the beginning, so that none of the problems arise later on to delay or derail the process.

New Patent Appeals Need to be Clear and Precise

The Board of Patent Appeals and Interferences (BPAI) is presently experiencing a large increase in the number of ex parte appeals. In 2006 (Financial Year), the Board received 3,349 ex parte appeals. In 2007, the Board expects to receive more than 4,000 ex parte appeals; and in 2008, it expects to receive over 5,000 such appeals.

In order to keep the process functioning smoothly in the face of this increasing pressure, the patent office has proposed a new set of rules which have been designed to help the Board avoid new bottlenecks.

According to the patent office,

 

These rules are proposed to change procedures in such a way as to allow the Board to continue to resolve ex parte appeals in a timely manner.

The proposed rules do not propose to change any of the rules relating to inter partes reexamination appeals. Nor do the proposed rules propose to change any of the rules relating to contested cases.

These new rules might make life easier for the Board, but they also demand more precision and clarity from applicants who are submitting fresh appeals, thereby putting an extra burden on them.

Improper Double Patenting leads to Patent Invalidation

The importance of following proper rules and procedures in the filing of patents cannot be overemphasized. Even tiny mistakes can lead to patent invalidation. The Patent Prospector highlights a particular case where ‘double patenting’ finally led to invalidation of both patents.

An excerpt from the post:

Toprol-XL® is a drug used to treat heart-related malfunctions. Astra owns two patents for its active ingredient, metoprolol succinate; patents which Astra asserted against generic drug makers seeking FDA approval; patents with a peculiar pedigree. The district court found Astra's metoprolol patents invalid owing to double patenting, and inequitable conduct, owing to the peculiar pedigree.

The company has now appealed the invalidity finding of one asserted patent, not pursuing any further action on the other. Proper knowledge and/ or guidance about rules and regulations concerning patents would have saved Astra quite a bit of trouble in this regard.

Drafting Medical Device Patents Requires Grasp of Technical Vocabulary

Can getting a single letter of the alphabet wrong in an issued patent spell disaster when it comes to litigating against infringers?  Unless the mistake is seen as being a minor typographical error that can be corrected by filing a certificate of correction, the answer is a resounding yes.

Hats off to Peter Zura of The 271 Patent Blog for his post on Central Admixure Pharmacy Services v. Advanced Cardiac Solutions (06-13-07).

 In this case, Central Admixture Pharmacy Services sued Advanced Cardiac Solutions for patent infringment relating to a chemical solution used duriing heart surgery. 

A certificate of correction was sought on the patent and was issued by the patent office to replace all instances of the word "osmolarity" with the word "osmolality".

You might be thinking that all the certificate does is change the "R" in osmolaRity with a "L" so that it reads osmolaLity.  Well, yes, BUT.... 

Whether or not the certificate of correction is proper depends upon whether the change is a clerical or typographical nature or if it constitutes new matter or would require re-examination.  Although the district court found the certificate of correction proper, the CAFC disagreed and found that the result of the correction was to broaden the claims since the corrected claims using the term osmolaLity cover less concentrated solutions than the original osmolaRity.

Yikes!  Needless to say, non-technical proofreaders or computerized spell-check and grammar checking programs (gasp!) are not adequate alternatives to a careful final review of a patent application by someone familiar with the technical vocabulary of the invention.